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Prevention of Urinary Tract Infection (UTI) in Persons With Spinal Cord Injury (SCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00309114
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Rabih Darouiche, Baylor College of Medicine

Brief Summary:

Urinary tract infection (UTI) is the most common infection in patients with spinal cord injury (SCI) and is linked to major undesired results or complications including death. The bladder of SCI patients, especially those with indwelling catheters, is usually colonized by bacteria, some of which do and others which do not cause symptoms of UTI. Bacteria that do not cause symptoms are often called benign colonizers and are often left untreated because they may provide some protection against infection with more harmful bacteria. This idea of using benign bacteria to prevent infections with symptoms is called bacterial interference. A prototype strain, Escherichia coli 83972, was shown to begin and continue for extended periods of time non symptom causing colonization of the human bladder and to hold back symptom causing infections of the neurogenic bladder. Data from pilot studies at two medical centers indicated that bacterial interference might be a useful therapy for reducing the rate or frequency of UTI in SCI patients. Because almost all SCI patients have a UTI at some time, and also the large costs of treating this infection, studying the impact of bladder colonization with E. coli 83972 on the rate of symptom causing UTI has an amazing potential for improving the quality of life of SCI patients and decreasing the cost of health care. Like with other preventive plans such as vaccination, for instance, it is important to explore the effectiveness of this new preventive approach. The project is a prospective, randomized, double blind, multi-center study that deals with specific pieces of bacterial interference in SCI patients.

HYPOTHESES: Placing non symptom causing bacteria (E. coli 83972) into SCI patients' bladders reduces the rate of symptom causing UTI.

A. SPECIFIC AIM: Determine how bladder colonization with E. coli 83972 or similar bacteria affects the rate of symptom causing urinary tract infections in a large group of SCI and Spina Bifida patients by conducting a prospective, randomized, placebo-controlled, multi-center clinical trial.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Procedure: bacterial interference Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Active intervention that includes bacterial interference using E. coli 83972 is compared with a placebo intervention.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of UTI in Persons With Spinal Cord Injury
Study Start Date : February 2004
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Interventions for Experimental Arm
Bacterial Interference with Escherichia coli 83972. Each bladder inoculation contains the study organism, E. coli 83972, suspended as a clear solution in sterile physiological saline.
Procedure: bacterial interference
Placebo Comparator: Interventions for Control Arm
Each bladder inoculation contains sterile physiological saline that does not contain the study organism.
Procedure: bacterial interference

Primary Outcome Measures :
  1. Putting E. coli 83972 into the bladder of SCI patients reduces the rate of symptomatic UTI. [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Study the affect of bladder colonization with E. coli 83972 on the rate of symptom causing UTI in a large group of SCI and Spina Bifida patients. [ Time Frame: 12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 15 years or older
  • Living in institutional or non-institutional settings
  • 6 months post spinal cord injury (SCI) prior to entry or have Spina Bifida
  • Loss of bladder function
  • Loss of normal bladder sensation
  • Selected in-patients involved in the Rehab I program
  • Catheter dependent, having either an indwelling urinary catheter or using an external catheter, intermittent catheterization, or vesical urinary diversion (original bladder, whole or in part, serves as the collection receptacle for urine) for bladder management.
  • Two or more urinary tract infections (UTI) within the 12 months prior to the study.
  • Capable of understanding the purpose of the study and providing informed consent to participate
  • Pursue appropriate follow-up over the course of the study.

Exclusion Criteria:

  • Any bladder stone(s)
  • Kidney stone(s) greater than 1 cm in size
  • Any obstructing kidney stone regardless of size
  • Nephrostomy tube(s)
  • Supravesical diversion (original bladder is no longer part of the collection receptacle for urine)
  • Congenital genitourinary anomaly that predisposes to UTI
  • Conditions anticipated to require recurrent antibiotic therapy for extraurogenital infection (e.g., recurrent pneumonia, decubitus ulcer)
  • Current immunosuppression
  • Vascular prosthesis
  • Congenital or acquired cardiac disease susceptible to vegetative infections
  • Bladder capacity of less than 50 cc
  • Individuals with known significant cognitive impairment resulting from trauma, disease, or congenital conditions
  • Women of childbearing age who engage in unprotected intercourse
  • Women who are currently pregnant will be included in the study
  • Women who become pregnant during the study will be discontinued from participation. Pregnant women who experience UTI or prolonged asymptomatic bacteriuria are at risk of bearing infants with low birth weight.
  • Children
  • Prisoners
  • Men and women with significant known mental illness or emotional disorders related to organic or inorganic causes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00309114

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United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
United States, Illinois
Rehab Institute Chicago
Chicago, Illinois, United States, 60611
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
Michael E Debakey VA Medical Center
Houston, Texas, United States, 77030
The Institute for Rehabilitation and Research (TIRR)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
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Principal Investigator: Rabih Darouiche, MD Baylor College of Medicine
Study Director: Barbara Trautner, MD, PhD Baylor College of Medicine
Publications of Results:
Other Publications:
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Responsible Party: Rabih Darouiche, Principal Investigator, Baylor College of Medicine Identifier: NCT00309114    
Other Study ID Numbers: 5R01HD043943-03 ( U.S. NIH Grant/Contract )
H-8393 ( Other Identifier: Baylor College of Medicine )
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rabih Darouiche, Baylor College of Medicine:
E coli
Additional relevant MeSH terms:
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Urinary Tract Infections
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Urologic Diseases